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Clinical trial to investigate the efficacy and safety of luspatercept in patients with low-risk MDS and ring sideroblastic phenotype (MDS-SA).
THE OBJECTIVE OF THE STUDY IS TO APPLY THE MAXIMUM DOSE OF LUSPATERCEPT ALLOWED BY APPROVAL AT INITIATION OF THERAPY. INSTEAD OF 1.0 MG/KG PER TREATMENT, A DOSE INCREASE TO 1.75 MG/KG BODY WEIGHT (HIGHER DOSE) IS INTENDED. THIS ADAPTED DOSE IS INTENDED TO ASCERTAIN THE FOLLOWING: CAN REDUCED TRANSFUSION DEPENDENCE BE ACHIEVED BY TREATMENT WITH LUSPATERCEPT AT A HIGHER DOSE ALONE? CAN THE HIGHER DOSE PROLONG THE TRANSFUSION-FREE PERIOD (RESPONSE) AND IMPROVE HEMOGLOBIN LEVELS IN MDS-SA PATIENTS? CAN RESPONSE BE IMPROVED IN MDS PATIENTS WHO HAVE NOT RESPONDED TO PREVIOUS THERAPY WITH LENALIDOMIDE (LEN) OR HYPOMETHYLATING AGENTS (HMA) (STUDY WITH A MAXIMUM OF 10 PATIENTS)? DOES LUSPATERCEPT THERAPY AFFECT THE PATIENT'S QUALITY OF LIFE AND WELL-BEING?
Technical Summary
- PHASE IIIB, OPEN-LABEL, SINGLE-ARM, OPEN-LABEL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LUSPATERCEPT IN PATIENTS WITH LOW-RISK MDS AND RING SIDEROBLASTIC PHENOTYPE (MDS-SA).
- Code EudraCT: 2020-004899-18
- Protocol number: LUSPLUS
- Promoter: GWT-TUD GmbH
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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